A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
UCB Biopharma SRL
Study ID
NCT03971422
Phase
PHASE3
Status
Completed

Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rozanolixizumab — DRUG
    Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.
  • Placebo — OTHER
    Subjects will receive placebo at pre-specified time points.

Study Details

The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).

Key Dates

Start date
Jun 3, 2019
Status verified
Dec 2025
Primary completion
Aug 31, 2021
Completion
Oct 26, 2021

Study Design

Enrollment
200 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dosage Regimen 1
    Study participants randomized to dosage regimen 1 will receive assigned dosage of rozanolixizumab at pre-specified time points during Treatment Period.
  • Experimental: Dosage Regimen 2
    Study participants randomized to dosage regimen 2 will receive assigned dosage of rozanolixizumab at pre-specified time points during Treatment Period.
  • Placebo Comparator: Placebo
    Study participants randomized to this arm will receive placebo.

Primary Outcome Measure

Change From Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score [ Time Frame: Baseline and Day 43 ]

Locations (30)

FacilityCityStateZIPSite coordinators
Mg0003 50081PhoenixArizona85013-
Mg0003 50082ScottsdaleArizona85251-
Mg0003 50072Los AngelesCalifornia90033-
Mg0003 50092OrangeCalifornia92868-
Mg0003 50097San FranciscoCalifornia94109-
Mg0003 50099San FranciscoCalifornia94117-
Mg0003 50101AuroraColorado80045-
Mg0003 50088Washington D.C.District of Columbia20037-
Mg0003 50120MiamiFlorida33144-
Mg0003 50122MiamiFlorida33136-
Mg0003 50073TampaFlorida33612-
Mg0003 50075AugustaGeorgia30912-
Mg0003 50323HonoluluHawaii96817-
Mg0003 50109ChicagoIllinois60637-
Mg0003 50114IndianapolisIndiana46202-
Mg0003 50074FairwayKansas66205-
Mg0003 50121LexingtonKentucky40536-
Mg0003 50110Ann ArborMichigan48109-
Mg0003 50102DetroitMichigan48202-
Mg0003 50104RochesterMinnesota55905-
Mg0003 50105St LouisMissouri63110-
Mg0003 50077New YorkNew York10021-
Mg0003 50086CharlotteNorth Carolina28207-
Mg0003 50117CharlotteNorth Carolina28204-
Mg0003 50090Winston-SalemNorth Carolina27157-
Mg0003 50076ColumbusOhio43210-
Mg0003 50089PhiladelphiaPennsylvania19140-
Mg0003 50096PhiladelphiaPennsylvania19104-
Mg0003 50084CharlestonSouth Carolina29425-
Mg0003 50113HoustonTexas77030-

Find similar trials in Phoenix, AZ

By research site
Mg0003 50081· Phoenix, AZMg0003 50082· Scottsdale, AZMg0003 50072· Los Angeles, CAMg0003 50092· Orange, CAMg0003 50097· San Francisco, CAMg0003 50099· San Francisco, CA

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